A Phase 2 Evaluation of a Novel Co-Formulation of Pramlintide and Regular Insulin to Improve Postprandial Glycemic Control in Adults with Type 1 Diabetes (T1D)

Objective: Pramlintide co-administration, used in conjunction with prandial insulin, has substantial clinical benefits to improve post-prandial glucose excursions, glycemic variability (GV) and time in range (TIR), but is associated with an increased injection burden that adversely affects adherence...

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Bibliographic Details
Published in:Journal of the Endocrine Society 2021-05, Vol.5 (Supplement_1), p.A327-A328
Main Authors: Edelman, Steven Victor, Conoscenti, Valentina, Junaidi, M Khaled, Close, Nicole, Sequeira, David, Nguyen, Anh
Format: Article
Language:English
Subjects:
Diabetes Mellitus and Glucose Metabolism
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Summary:Objective: Pramlintide co-administration, used in conjunction with prandial insulin, has substantial clinical benefits to improve post-prandial glucose excursions, glycemic variability (GV) and time in range (TIR), but is associated with an increased injection burden that adversely affects adherence and persistence. A novel, fixed-ratio co-formulation of pramlintide and regular insulin (XP-3924) was evaluated in a phase 2 single injection study measuring XP-3924 pharmacokinetics (PK), glucose pharmacodynamics (PD), and its effects upon overall glycemic control. Methods: This was a Phase 2 randomized, open-label, active comparator-controlled, three-period cross-over study, which enrolled 18 adults with T1D to compare the PK and PD, glycemic affects and safety and tolerability of a single dose of XP-3924, to co-administration of regular insulin (Humulin® R) and pramlintide (Symlin®), and to an injection of regular insulin (RI) alone. Subjects were randomly allocated to a sequence of three treatments: XP-3924 (with 50% insulin reduction based their insulin to carbohydrate ratio), RI, or co-administration (RI with 50% insulin reduction plus a comparable pramlintide dose, co-administered as separate injections). The study drugs were administered subcutaneously 30 minutes before a 75-gram oral glucose challenge and glucose levels were monitored for 6 hours. Results: XP-3924 treatment resulted in a 62.3% reduction of hyperglycemia (blood glucose AUC0-3 hr >180 mg/dL) after the glucose challenge when compared to RI (p
ISSN:2472-1972
2472-1972
DOI:10.1210/jendso/bvab048.669